Regulatory Information

AAB-MLE offers prompt, knowledgeable customer service including experienced laboratory professionals to assist you with your regulatory questions.

Contact AAB-MLE Technical Support or your State Agency if you have questions about laboratory regulations.

CLIA Regulations

The Clinical Laboratory Improvement Amendments of 1988 (CLIA) are U.S. federal standards applicable to all sites that test human specimens for health assessment or to diagnose, prevent, or treat disease. The objective of the CLIA program is to ensure quality laboratory testing. The Centers for Medicare & Medicaid Services (CMS) regulates all non-research laboratory testing performed on humans in the U.S. through the CLIA program, in partnership with the CDC and FDA.  Although CLIA is a federal program, CMS State Agencies are responsible for laboratory oversight and maintaining CLIA certification records. Some states have laboratory licensing laws separate from the CLIA regulations, so please check with your State before your lab begins any patient testing.

Educational Resources